DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"a microneedle size device coupled to the microneedle and configured to set a length of the microneedle extending from the chamber" in claim 1; and
"a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir" in claim 1;
“a microneedle temperature control assembly configured to control the temperature of the biomaterial fluid in the microneedle ” in newly added claim 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention.
Regarding claim 22, the new matter is “the temperature control assembly includes a first case surrounding at least a portion of the reservoir and a first heater positioned within the first case, the first heater in a heat exchange relationship with the reservoir for maintaining the temperature of the reservoir, and
the needle temperature control assembly including a second case surrounding at least a portion of the microneedle and a second heater positioned within the second case, the second heater in a heat exchange relationship with the microneedle and the biomaterial fluid.”
The original disclosure makes no mention of a case surrounding a portion of the reservoir with a first heater positioned within the first case. Specifically, Applicant discloses a temperature control assembly that includes a sleeve 43 that may “fully or partially cover the syringe” (see specification at para [0070]). In the same paragraph, Applicant discloses “a resistive element to control the temperature” (presumably referring to the temperature of the biomaterial in the syringe). But there is no disclosure that the sleeve itself has a heater therein, as claimed.
Further, Applicant discloses a “microneedle insulating case” (see paras [0061] and [0071]), presumably corresponding to the claimed second case surrounding at least a portion of the microneedle. But there is no disclosure of a second heater positioned within this case, as claimed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 4, 15, 16, 21, 22, 23 and all claims depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 3, 4, 15, 16, 21, 22 and 23 recite "the microneedle". However, claim 1, upon which the aforementioned claims depend, recites two microneedles (i.e., a microneedle part of the claimed device, and a microneedle formed in-situ). It is not clear what specific microneedle is referenced in the dependent claims.
For the purpose of examination, "the microneedle" in the dependent claims will be interpreted to refer to the microneedle part of the claimed device, rather than the microneedle formed in-situ.
Claim 21 recites “the biomaterial fluid in the microneedle”, which lacks antecedent basis in the claims. Further, even assuming that claim 21 had antecedent basis for this term, it is not clear whether the microneedle in claim 21 refers to the microneedle coupled to the body or the in-situ microneedle.
Claim 22 recites the term “the temperature control assembly”, but claim 21 (upon which claim 22 depends) recites “a microneedle temperature control assembly” and claim 1 (upon which claim 21 depends) recites “a temperature control assembly”. It is not clear what specific “temperature control assembly” is referenced in claim 22.
Claim 22 also recites “the needle temperature control assembly”, which lacks antecedent basis in the claims. As best understood, this term was intended to refer to the “microneedle temperature control assembly” in claim 21.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7 and 10-17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (U.S. Pub. 2020/0121769 A1, hereinafter "Chang"), in view of Eriksson (U.S. Pub. 2004/0058882 A1, hereinafter “Eriksson”) in view of Merchant et al (U.S. Pub. 2013/0197427 A1, hereinafter "Merchant").
Regarding claim 1, Chang discloses a device for forming in-situ microneedles in tissue, the device comprising:
a body (shown in Fig. 3, but not specifically labeled, to include the actuator 13, ejector 10, and housing for the display 12 and electrical components 6, 7, 8, 9);
a microneedle coupled to the body (one or more microneedles located on head 10; see Fig. 3), the microneedle positioned within a chamber (head 10) at a distal end of the body;
a reservoir 2 (see Fig. 3) coupled to the body, the reservoir adapted for a biomaterial fluid (a variety of bioactive materials and agents described in paras [0007]-[0026], the reservoir in fluid communication with the microneedle (see Figs. 3 and 6);
a first motor 4 (see Fig. 3 and para [0126]) coupled to the body and the reservoir (the motor is coupled to the piston 3 of the reservoir and is supported by the housing components), the first motor configured to activate the reservoir to expel the biomaterial fluid to the microneedle (see para [0126]: motor activates the piston 3 of the reservoir to expel biomaterial into the needle head 1);
a second motor coupled to the body and the microneedle (see para [0610], disclosing that a motor controls the speed and frequency of the needle punctures);
a microneedle size device 5 (see Fig. 3) coupled to the microneedle and configured to set a length of the microneedle extending from the chamber (see para [0126], cam system and dial 5 is used to adjust needle injection depth); and
a user interface (display 12; see Fig. 3) configured to receive input from a user to control the microneedle to penetrate the tissue to inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue (display 12 is a manual or touch screen control panel; it is understood to control the information processor 9 in order to control ejection volume, for example; see para [0126]).
It is noted that Chang does not appear to disclose that the reservoir is offset from the body.
Eriksson discloses a device for forming in-situ microneedles in tissue, the device comprising:
a body 60 (see Fig. 7);
a microneedle coupled to the body (one or more microneedles 75; see Fig. 7 and para [0116], the microneedle positioned within a chamber 134 (see Fig. 11) at a distal end of the body;
a reservoir 68 (see Fig. 7) coupled to and offset from the body (see Fig. 7, showing the reservoir longitudinal axis offset from the longitudinal axis of the body), the reservoir adapted for a biomaterial fluid (a variety of bioactive materials and genetic agents described in paras [0033]-[0039], the reservoir in fluid communication with the microneedle (via syringe dispenser tube 73; see Fig. 7);
a first motor 90 (see Fig. 8) coupled to the body and the reservoir (the motor is coupled to the piston 82 of the reservoir), the first motor configured to activate the reservoir to expel the biomaterial fluid to the microneedle (see para [0122]: motor activates the piston 82 of the reservoir to expel biomaterial);
a second motor 94 (see Fig. 8) coupled to the body and the microneedle (see para [0123], disclosing that a motor controls the speed and frequency of the needle punctures);
a user interface (on control 54; see para [0135]) configured to receive input from a user to control the microneedle to penetrate the tissue to inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue (using knob 170, for instance; see para [0135]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chang so that the reservoir is offset from the body, as taught by Eriksson. Eriksson demonstrates that positioning a biomaterial reservoir offset from a microneedle body and fluidly connecting the reservoir to the microneedles by tubing was known at the time of the invention. Applying this known arrangement would have merely involved repositioning the reservoir relative to the microneedle body while maintaining the fluid connection therebetween (i.e., the fluid connection between the reservoir and the base end of the microneedles, disclosed in para [0476] of Chang), and would have yielded the predictable result of providing the biomaterial from the reservoir to the microneedles through the tubing. The modification could have also provided an advantage over the existing design of Chang by permitting easier replacement of the reservoir, and would have amounted to little more than a design choice to rearrange the reservoir so that it is offset from the body. Moreover, Applicant has not disclosed any particular problem to be solved by providing the reservoir offset from the body, much less the criticality of doing so.
It is further noted that Chang, in view of Eriksson, does not appear to disclose a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir.
Merchant discloses a microneedle device and a reservoir, comprising a temperature control assembly coupled to the reservoir, and configured to set and maintain a temperature of the reservoir (see para [0077], disclosing an active heating/cooling mechanism to control the temperature of the fluid at a predetermined setting).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chang, in view of Eriksson, by incorporating a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir, in order to control the temperature of the fluid within the reservoir, thereby promoting a desired therapeutic and/or material effect of the fluid within the reservoir).
Regarding claim 2, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the microneedle is configured to reciprocate and extend from a distal end of the device to penetrate the tissue (see para [0610], disclosing that the home position of the needle and the traveling length of the needle will be controlled by variable configurations in a slider crank mechanism).
Regarding claim 3, Chang, in view of Eriksson and Merchant, discloses the device of claim 1, wherein the user interface is configured to receive input to control a speed, a depth, a residence time, or a combination thereof of the microneedle (display 12 is a manual or touch screen control panel; it is understood to control the information processor 9 to ensure proper dosage control, width and depth control, speed control, composition and formulation control and any safety measures, as in para [0609]).
Regarding claim 4, Chang, in view of Eriksson and Merchant discloses the device of claim 1, further comprising a controller configured to coordinate communication between the first motor, the second motor, and the microneedle (information processor 9 ensures proper dosage control, width and depth control, speed control, composition and formulation control and any safety measures, which are understood to require coordination between the motors and the microneedle which affect the aforementioned control variables).
Regarding claim 7, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the device is configured to be handheld by a user or the device is configured to be controlled by the user through a robotic assembly (see para [0124], disclosing that the device is handheld; and see para [0585], disclosing that the device can be handheld or remotely operated using robotic technology).
Regarding claim 10, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the biomaterial fluid comprises a polymer (see para [0198], disclosing collagen; see also para [0473], disclosing protein).
Regarding claim 11, Chang, in view of Eriksson and Merchant discloses the device of claim 10, wherein the polymer comprises a synthetic polymer, a naturally occurring polymer, or a combination thereof (collagen and protein can be either synthetic or naturally occurring).
Regarding claim 12, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the biomaterial fluid comprises a biologically active agent, a particle-laden solution, or a combination thereof (see paras [0056]- [0061] and [0083]-[0098]).
Regarding claim 13, Chang, in view of Eriksson and Merchant discloses the device of claim 12, wherein the biologically active agent comprises a protein (see para [0473]), a carbohydrate (see para [0007] disclosing hyaluronic acid), a small molecule drug (see para [0057] disclosing minoxidil), a cell (see para [0007] disclosing stem cells), or a combination thereof.
Regarding claim 14, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the biomaterial fluid has a viscosity of less than 1 Pa.s or has a shear thinning property (see disclosure of micro hyaluronic acid FCH, which has shear thinning properties by virtue of its ultra-low viscosity)
Regarding claim 15, Chang, in view of Eriksson and Merchant discloses the device of claim 1, wherein the microneedle has a hollow core (see para [0486] disclosing that the device includes hollow needles).
Regarding claim 16, Chang, in view of Eriksson and Merchant discloses the device of claim 1, The device of claim 1, wherein the device includes a plurality of the microneedles (see Fig. 3 showing a plurality of the same microneedles located on head 10).
Regarding claim 17, Chang, in view of Eriksson and Merchant discloses the device of claim 1, further comprising a crosslinking source (see para [0236] disclosing a composition with a protein cross-linking agent), wherein the crosslinking source comprises a chemical source (a protein cross-linking agent as previously described).
Regarding claim 23, the combination of Chang and Eriksson would have provided a conduit extending from the reservoir to the chamber and wherein the biomaterial fluid flows from the reservoir to the microneedle through the conduit (for example, the conduit 73 already disclosed in Eriksson that provides the fluid communication between the reservoir and the microneedle).
Claims 5, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chang, in view of Eriksson and Merchant, further in view of Hynes et al (U.S. Pub. 2006/0271014 A1, hereinafter "Hynes").
Regarding claim 5, Chang, in view of Eriksson and Merchant discloses the device of claim 1, further comprising an assembly, and wherein the reservoir is removably coupled to the body, but does not appear to disclose that the assembly includes the temperature control assembly which is also removably coupled to the body.
Further, regarding claim 6, Chang, in view of Eriksson and Merchant discloses the device of claim 5, but does not appear to disclose that the reservoir includes a syringe, and wherein the temperature control assembly includes a syringe heater and a thermal insulating case, wherein the syringe includes the biomaterial fluid, and wherein the syringe heater is configured to provide heat to the syringe.
Further, regarding claim 9, Chang, in view of Eriksson and Merchant does not appear to disclose the device of claim 1, wherein the temperature control assembly is configured to maintain a temperature of the biomaterial fluid at about 4 degrees C to about 80 degrees C.
Hynes discloses a syringe for delivering a medical fluid, comprising a temperature control assembly for providing heat to the syringe, in the form of a removable heater (e.g., phase change material 52 located in compartment 58; see para [0036] and Fig. 3) and thermal insulating case 54 (see Fig. 3).
Hynes further discloses that the medical fluid held in the syringe is heated to about 21 degrees C and/or 37 degrees C (see para [0030]).
A skilled artisan would have found it obvious at the time of the invention to provide the temperature control assembly to be removable with the reservoir, as taught in Hynes, in order to reduce the cooling rate of medical fluid held inside the syringe, such as for reducing the viscosity of the fluid (see Hynes at para [0003]) with a reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chang, in view of Eriksson and Merchant, further in view of Cleary et al (U.S. Pub. 20050228340 A1, hereinafter "Cleary").
Regarding claim 8, it is noted that Chang, in view of Eriksson and Merchant does not appear to disclose that the reservoir comprises at least two different biomaterial fluids.
Cleary discloses a device for delivering drugs to the body, comprising a reservoir 18 (see Fig. 9) that can contain multiple separate compartments 18a, 18b to hold two or more different ingredients (see para [0084]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Merchant in view of Cleary, at the reservoir comprises at least two different biomaterial fluids, in order to utilize the delivery of multiple ingredients that may not be compatible with one another (see Cleary at para [0084]), with a reasonable expectation of success.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Chang, in view of Eriksson and Merchant, further in view of Elkins et al (U.S. Pub. 2008/0183164 A1, hereinafter “Elkins”).
Regarding claim 21, it is noted that Chang, in view of Eriksson and Merchant, does not appear to disclose the device of claim 1, further comprising a microneedle temperature control assembly configured to control the temperature of the biomaterial fluid in the microneedle.
Elkins discloses a microneedle temperature control assembly that is configured to control the temperature of biomaterial fluid within the microneedles (see Fig. 5A, showing a microneedle applicator casing 112 having a heating element 120 and microneedles 54 disposed therein).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chang, in view of Eriksson and Merchant, according to the teaching in Elkins, in order to maintain a proper temperature of the biomaterial within the microneedles, with a reasonable expectation of success).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Chang, in view of Eriksson and Merchant, further in view of Elkins, further in view of Udagawa (U.S. Pub. 2018/0140778 A1, hereinafter “Udagawa”).
Regarding claim 22, it is noted that Chang discloses a case 1 (see Fig. 3) that surrounds a portion of the microneedles, and the combination of Chang with Elkins teaches providing a heating element within a case along with microneedles (as already taught in Elkins as explained above), but Chang, in view of Eriksson, Merchant and Elkins does not appear to disclose that the reservoir temperature control assembly includes a first case surrounding at least a portion of the reservoir and a first heater positioned within the first case, the first heater in a heat exchange relationship with the reservoir for maintaining the temperature of the reservoir.
Udagawa discloses a liquid injector and a case 141 that surrounds the liquid injector, with a heater (in the form of a heating sheet 141a) that is positioned within the case (i.e., on the inside of the case against the reservoir), that keeps a liquid in the syringe warm at a predetermined temperature (see para [0109]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chang, in view of Eriksson, Merchant and Elkins, as taught in Udagawa, as a well-known way for carrying out the function already taught in Merchant, in particular, heating the reservoir, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed in the Remarks on 06/24/2026 have been fully considered.
Regarding claim interpretation, Applicant argued that “a microneedle size device … configured to set a length of the microneedle extending from the chamber” and “a temperature control assembly … configured to set and maintain a temperature of the reservoir,” both recited in claim 1, should not be interpreted under 112(f) because the terms used in the claim have sufficiently definite meaning as the name for structure (see Remarks, pg. 6).
The presumption that 35 U.S.C. 112(f) does not apply to a claim limitation that does not use the term "means" is overcome when "the claim term fails to 'recite sufficiently definite structure' or else recites 'function without reciting sufficient structure for performing that function.'" (See MPEP 2181(I).)
The terms “microneedle size” and “temperature control” merely describe function related to the generic terms “device” and “assembly,” respectively (it is noted that Applicant has acknowledged that “device” is an example of a generic placeholder; see Remarks, pg. 6). Applicant has not provided persuasive evidence that “microneedle size device” and “temperature control assembly” have definite structure as claimed.
Though Applicant has cited the specification to describe examples of a “microneedle size device” and a “temperature control assembly” (see Remarks, pg. 7). Applicant has provided, by way of the specification, a description of exemplary structure that corresponds to the claim terms sufficient to meet the requirements of 35 U.S.C. 112(a) and (b).
Regarding the rejections under 35 U.S.C. 112(b), Applicant argued that the terms “the microneedle” in claims 2, 3, 14, 15 and 16 distinctly refer back to “a microneedle coupled to the body” of claim 1 (see Remarks, pg. 7). But Applicant’s own arguments acknowledge that “an in-situ microneedle” is a type of microneedle (see Remarks, pg. 7, stating that “the second instance of ‘microneedle’ is referred to as ‘an in-situ microneedle’”). Therefore, the ambiguity arises not because claim 1 recites two different microneedles, but because the dependent claims refer back to a previously recited microneedle without unambiguously specifying which one of the two microneedles was intended to be referenced.
Applicant’s own claim drafting further demonstrates Applicant’s intent to clearly differentiate multiple structures of the same type. For example, where Applicant intended to define multiple motors, Applicant recited “a first motor” and “a second motor” in claim 1. The Examiner suggests that comparable identifiers be provided to clearly distinguish the two recited microneedles.
Regarding the rejections under 35 U.S.C. 103, Applicant argued that Chang does not disclose a reservoir coupled to and offset from the body (see Remarks, pg. 8). This argument is persuasive, and the rejections have been withdrawn. However, new grounds of rejection, necessitated by the amendments, have been applied in view of the newly applied reference of Eriksson.
Further, regarding dependent claim 17, Applicant argued that Chang does not disclose the claimed crosslinking source (see Remarks, pg. 9). But Chang at para [0236] (previously cited) discloses a crosslinking source in the form of a composition with a protein cross-linking agent, which meets the claimed limitation of a “chemical source.” For this reason, the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
09/18/2026
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